Methylphenidate transdermal system: a multisite, open-label study of dermal reactions in pediatric patients diagnosed with ADHD.
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ABSTRACT: OBJECTIVE:To characterize dermal reactions and examine methylphenidate (MPH) sensitization in subjects receiving methylphenidate transdermal system (MTS). METHOD:This multicenter, open-label, dose-optimization study utilized MTS doses of 10, 15, 20, and 30 mg in children aged 6 to 12 years, inclusive (N = 305), with a DSM-IV-TR primary diagnosis of attention-deficit/hyperactivity disorder. The study was conducted between January 8, 2007, and August 23, 2007. Subjects wore MTS on their hips for 9 hours per day, alternating sides daily for a total of 7 weeks. Assessments included the Experience of Discomfort scale, Transdermal System Adherence scale, and Dermal Response Scale (DRS; 0 = no irritation, 7 = strong reaction). On-study reevaluations were conducted to characterize DRS scores ? 4. Epicutaneous allergy patch testing was conducted for DRS scores ? 6, persistent DRS scores ? 4, DRS score increase following an assessment of ? 4, or DRS scores of 4 or 5 following elective discontinuation. RESULTS:Approximately half of subjects experienced definite erythema at the patch site that generally dissipated within 24 hours. Four subjects experienced a DRS score of 4 (1%): erythema in 1 subject resolved on study treatment, 2 cases resolved poststudy and subjects tolerated oral MPH, and 1 subject discontinued treatment. The latter subject was referred for patch testing and was diagnosed with allergic contact sensitization to MPH. CONCLUSIONS:Few severe dermal effects were seen with MTS treatment. Dermal reactions were characterized as contact dermatitis and dissipated rapidly. On patch testing, 1 subject (0.3%) manifested sensitization to MPH. TRIAL REGISTRATION:clinicaltrials.gov Identifier: NCT00434213.
SUBMITTER: Warshaw EM
PROVIDER: S-EPMC3067997 | biostudies-literature | 2010
REPOSITORIES: biostudies-literature
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